Safety Study of Three Formulations of the Dermal Implant ELAPR

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elastagen Pty Ltd
ClinicalTrials.gov Identifier:
NCT01467778
First received: March 22, 2011
Last updated: November 7, 2011
Last verified: November 2011

March 22, 2011
November 7, 2011
December 2010
March 2011   (final data collection date for primary outcome measure)
Safety and tolerability measured by the amount of adverse events and serious adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of a single course of intradermal injections of ELAPR when administered to healthy subjects by reported adverse events and serious adverse events
Same as current
Complete list of historical versions of study NCT01467778 on ClinicalTrials.gov Archive Site
Persistence [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
To determine implant persistence by histopathology and clinical observation
Same as current
Not Provided
Not Provided
 
Safety Study of Three Formulations of the Dermal Implant ELAPR
A Phase I Study to Assess the Safety of Three Formulations of the Dermal Implant ELAPR in Healthy Subjects

This is a Phase I study to assess the safety of three formulations of the dermal implant ELAPR.

A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in healthy subjects.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Skin Conditions
  • Device: ELAPR
    ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.
    Other Names:
    • Other Names:
    • Tropoelastin 0.1ml SC implant
  • Device: ELAPR
    Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003
    Other Name: Tropoelastin 0.1ml SC implant
  • Active Comparator: ELAPR001
    Tropoelastin 0.1ml SC implant
    Interventions:
    • Device: ELAPR
    • Device: ELAPR
  • Active Comparator: ELAPR002
    Tropoelastin 0.1ml SC implant
    Interventions:
    • Device: ELAPR
    • Device: ELAPR
  • Active Comparator: ELAPR003
    Tropoelastin 0.1ml SC implant
    Interventions:
    • Device: ELAPR
    • Device: ELAPR
  • Placebo Comparator: Saline
    Normal Saline 0.9%
    Interventions:
    • Device: ELAPR
    • Device: ELAPR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2011
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Good general health status

Exclusion Criteria:

  • Clinically significant abnormalities of haematology or biochemistry testing
  • Bleeding diathesis, anticoagulant drugs,thrombocytopenia or clinically significant prolonged APTT or PT
  • Chronic use of aspirin, other non-steroidal antiinflammatory drugs or other anti-platelet agents
  • History of keloid formation
  • Systemic corticosteroids within last 12 weeks
  • Diabetes or metabolic disorders
  • Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
  • Pregnancy/lactation
  • A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01467778
ELAPR-P1
No
Elastagen Pty Ltd
Elastagen Pty Ltd
Not Provided
Principal Investigator: Carlos China, MBBS Woolcock Institute of Medical Research
Elastagen Pty Ltd
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP